FDA已经批准罗氏公司一种治疗基底细胞癌(basal cell carcinoma，BCC)的新药Erivedge（vismodegib）。这是有史以来第一个被批准治疗基底细胞癌的药物。
Erivedge（vismodegib）
Erivadge是由瑞士制药商罗氏的基因技术公司（Genentech）生产，适用于无法开刀或使用化疗的癌症晚期患者，及癌细胞已经扩散到其他身体器官的病人。患者每日服用一次。
基因技术公司称这种药在一到两个星期内上市。
Erivadge药瓶上的标签警告，此药若用于孕妇将可能导致婴儿死亡，它最常见的副作用包括肌肉痉挛，脱发，消瘦，腹泻，疲劳，改变或丧失味觉，食欲下降，便秘，呕吐。
FDA原本计划于3月8日决定是否批准Erivedge，现在提前做出批准决定。由于没有治疗基底细胞癌的药物，这次的审查比原计划提前6个月。
关于基底细胞癌
基底细胞癌(basal cell carcinoma，BCC) 是皮肤癌最常见类型之一，又称基底细胞上皮瘤(basal cell epithelioma) 、基底样细胞瘤侵蚀性溃疡等，是源于表皮基底细胞或毛囊外根鞘的上皮性低度恶性肿瘤。典型的基底细胞癌的治疗方法包括冷冻或手术切除癌变区域。
每年大约有280万美国人罹患基底细胞癌。皮肤癌基金会称，基底细胞癌(BCCs)一般不致命，但如果任其继续生长将可能导致毁容。有少量的案例里基底细胞癌可能扩散到身体其他器官，并最后导致死亡。
Indication
Erivedge is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma, that has spread to other parts of the body or that has come back after surgery or that your healthcare provider decides cannot be treated with surgery or radiation.
Possible Serious Side Effects and Additional Important Safety Information
What is the most important information I should know about Erivedge?
- Erivedge can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects
- For females who can become pregnant:
- You should talk with your healthcare provider about the risks of Erivedge to your unborn child
- Your healthcare provider should do a pregnancy test within 7 days before you start taking Erivedge to find out if you are pregnant
- In order to avoid pregnancy, you should start using highly effective birth control before you start Erivedge, and continue during treatment and for 7 months after your last dose. Talk with your healthcare provider about what birth control method is right for you during this time
- Talk to your healthcare provider right away if you have unprotected sex or if you think that your birth control has failed
- Tell your healthcare provider right away if you become pregnant or think that you may be pregnant
- For males:
- You should always use a condom with a spermicide, even if you have had a vasectomy, during sex with female partners while you are taking Erivedge and for 2 months after your last dose to protect your female partner from being exposed to Erivedge
- Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking Erivedge
Exposure to Erivedge during pregnancy:
If you think that you or your female partner may have been exposed to Erivedge during pregnancy, talk to your healthcare provider right away. Pregnant women are encouraged to participate in a program that collects information about exposure to Erivedge during pregnancy, and the effects on the mother and her unborn child. This program is called the Erivedge pregnancy pharmacovigilance program. You may participate in this program by calling the Genentech Adverse Event Line at (888) 835-2555
What should I tell my healthcare provider before taking Erivedge?
- If you are pregnant or plan to become pregnant
- If you are breast-feeding or plan to breast-feed. It is not known if Erivedge passes into your breast milk. You and your healthcare provider should decide if you will take Erivedge or breast-feed. You should not do both
What should I avoid while taking Erivedge?
Do not donate blood or blood products while you are taking Erivedge and for 7 months after your last dose
What are the possible side effects of Erivedge?
The most common side effects of Erivedge are:
- Muscle spasms
- Hair loss
- Change in how things taste or loss of taste
- Weight loss
- Tiredness
- Nausea
- Diarrhea
- Decreased appetite
- Constipation
- Vomiting
- Joint aches
Because everyone is different, it is not possible to predict what side effects any one person will have. If you have questions or concerns about side effects, you should talk to your doctor.